Colorectal NeoplasmsNCT01492049
R-21 Colorectal Cancer Screening (CRCS) Pilot Trial
A study testing CRCS patient decision aid (PtDA) video, Questionnaires and Essential Hypertension video in people with Colorectal Neoplasms, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this study is to test patient education program for decision making about colorectal cancer (CRC) screening in community health centers. Read more about this study
- Who is it for?
- Ages 49 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- CRCS patient decision aid (PtDA) video, Questionnaires and Essential Hypertension video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2012to 12 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 49 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female patients
- 49 -75 years of age
- English-speaking African American or Spanish-speaking Hispanic patients (upon approval of spanish language arm)
Who cannot join
- History of colorectal cancer
- History of polyps
- Any inflammatory bowel disease (IBD), e.g. Crohn's disease or ulcerative colitis
- Family history of colorectal cancer in a first degree relative
- Had fecal occult blood test (FOBT) in the past year, flexible sigmoidoscopy in the past 5 years or colonoscopy in the past 10 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Harris County Hospital District
Houston, Texas, 77030
About this study
Official title: Pilot Trial - Promoting Health Literacy for Colorectal Cancer Screening
The goal of this study is to test patient education program for decision making about colorectal cancer (CRC) screening in community health centers.
Read the detailed description
Baseline Visit:
If you agree to take part in this study, you will complete a questionnaire that asks demographic questions (such as your age and sex) and questions about colorectal cancer. It should take about 10-15 minutes to complete.
You will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. If you are in Group 1, you will view a colorectal cancer program. If you are in Group 2, you watch a program on Essential Hypertension.
You will watch the program on a laptop in the clinic. The program is about 30 minutes long. After you watch the program, you will complete a questionnaire that asks what you thought about the program and some questions about understanding medical information. It should take about 5-10 minutes to complete the questionnaire.
You will be called 1-3 weeks after your baseline visit to complete a questionnaire by phone. The call should last about 20-25 minutes. You will be asked if you discussed colorectal cancer screening tests with your doctor, your preferences for colorectal cancer screening tests, and if any colorectal cancer screening tests were ordered.
At Month 3, your medical record will be reviewed by the study staff.
Length of Study:
You will be off study after your medical record is reviewed at Month 3.
This is an investigational study.
Up to 180 participants (90 Hispanic and 90 African-American) will take part in this study. All participants will be enrolled from the Harris County Hospital District and Kelsey-Seybold outpatient clinics.
- Conditions
- Colorectal Neoplasms
- Being tested
- CRCS patient decision aid (PtDA) video, Questionnaires, Essential Hypertension video
- Keywords
- Colorectal Neoplasms, Promoting Health Literacy, Patient education program, Colorectal Cancer Screening, CRCS, Patient decision aid, PtDA, Video, Questionnaires, Surveys
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRCS patient decision aid (PtDA) videoBehavioural
Participant views PtDA program video in same room as research assistant who offers instruction as needed.
QuestionnairesBehavioural
Also called survey
Up to 3 questionnaires (baseline demographics, post-intervention evaluation, and follow up) taking from 5 to 25 minutes to complete each.
Essential Hypertension videoBehavioural
Participant views Essential Hypertension video in same room as research assistant who offers instruction as needed.
| Study group | Role | What they receive |
|---|---|---|
| Patient Decision Aid (PtDA) | Experimental | Participants view Patient decision aid (PtDA) video. Receives: Behavioral: CRCS patient decision aid (PtDA) video; Behavioral: Questionnaires |
| Control | Active comparator | Participants view a video on Essential Hypertension. Receives: Behavioral: Questionnaires; Behavioral: Essential Hypertension video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal cancer screening (CRCS) Rate of Participants
CRCS rates in the patient decision aid and control subjects based on medical record reviews, physician orders for screening endoscopy after the baseline visit also from medical record reviews, and intentions to complete CRCS based on self-report.
Measured: 24 months for study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2011 (estimated)
- Study start7 Aug 2012
- Primary completion12 Sep 2018
- Study completion12 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Robert Volk, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492049
- Sponsor's protocol ID
- 2010-0698
- Other IDs
- R21CA132669, NCI-2015-01899
- Status last verified
- Nov 2018
- First submitted
- 12 Dec 2011
- Last updated
- 19 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial - Promoting Health Literacy for Colorectal Cancer Screening
- ClinicalTrials.gov ID
- NCT01492049
- Acronym / sponsor ID
- 2010-0698
- Conditions
- Colorectal Neoplasms
- Keywords
- Colorectal Neoplasms, Promoting Health Literacy, Patient education program, Colorectal Cancer Screening, CRCS, Patient decision aid, PtDA, Video
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Aug 2012 (actual)
- Primary completion
- 12 Sep 2018 (actual)
- Study completion
- 12 Sep 2018 (actual)
- First posted
- 14 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to test patient education program for decision making about colorectal cancer (CRC) screening in community health centers.
Detailed description
Baseline Visit:
If you agree to take part in this study, you will complete a questionnaire that asks demographic questions (such as your age and sex) and questions about colorectal cancer. It should take about 10-15 minutes to complete.
You will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. If you are in Group 1, you will view a colorectal cancer program. If you are in Group 2, you watch a program on Essential Hypertension.
You will watch the program on a laptop in the clinic. The program is about 30 minutes long. After you watch the program, you will complete a questionnaire that asks what you thought about the program and some questions about understanding medical information. It should take about 5-10 minutes to complete the questionnaire.
You will be called 1-3 weeks after your baseline visit to complete a questionnaire by phone. The call should last about 20-25 minutes. You will be asked if you discussed colorectal cancer screening tests with your doctor, your preferences for colorectal cancer screening tests, and if any colorectal cancer screening tests were ordered.
At Month 3, your medical record will be reviewed by the study staff.
Length of Study:
You will be off study after your medical record is reviewed at Month 3.
This is an investigational study.
Up to 180 participants (90 Hispanic and 90 African-American) will take part in this study. All participants will be enrolled from the Harris County Hospital District and Kelsey-Seybold outpatient clinics.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Decision Aid (PtDA) | Experimental | Behavioral: CRCS patient decision aid (PtDA) video, Behavioral: QuestionnairesParticipants view Patient decision aid (PtDA) video. |
| Control | Active comparator | Behavioral: Questionnaires, Behavioral: Essential Hypertension videoParticipants view a video on Essential Hypertension. |
Who may qualify
- Ages
- 49 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female patients
- 49 -75 years of age
- English-speaking African American or Spanish-speaking Hispanic patients (upon approval of spanish language arm)
Key exclusion criteria (5 listed)
- History of colorectal cancer
- History of polyps
- Any inflammatory bowel disease (IBD), e.g. Crohn's disease or ulcerative colitis
- Family history of colorectal cancer in a first degree relative
- Had fecal occult blood test (FOBT) in the past year, flexible sigmoidoscopy in the past 5 years or colonoscopy in the past 10 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRCS patient decision aid (PtDA) videoParticipant views PtDA program video in same room as research assistant who offers instruction as needed. | Behavioural | Patient Decision Aid (PtDA) |
| QuestionnairesAlso: surveyUp to 3 questionnaires (baseline demographics, post-intervention evaluation, and follow up) taking from 5 to 25 minutes to complete each. | Behavioural | Control, Patient Decision Aid (PtDA) |
| Essential Hypertension videoParticipant views Essential Hypertension video in same room as research assistant who offers instruction as needed. | Behavioural | Control |
Primary outcome
Colorectal cancer screening (CRCS) Rate of Participants
Time frame: 24 months for study duration
CRCS rates in the patient decision aid and control subjects based on medical record reviews, physician orders for screening endoscopy after the baseline visit also from medical record reviews, and intentions to complete CRCS based on self-report.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Volk, PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRCS patient decision aid (PtDA) video, Questionnaires and Essential Hypertension video in people with Colorectal Neoplasms, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colorectal cancer screening (CRCS) Rate of Participants (time frame: 24 months for study duration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2018.